K945458

Substantially Equivalent

VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM

Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code
GIM
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin Lake, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GIM

product code GIM
Malfunction
1,325
Total
1,325

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.